Myriad myRisk® Hereditary Cancer Test Demonstrates the Magnitude of Breast and Ovarian Cancer Risk in Nearly 100,000 Patien...
June 06 2016 - 7:05AM
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced that two
analyses demonstrating the utility of the Myriad myRisk® Hereditary
Cancer test will be featured in oral presentations at the 2016
American Society of Clinical Oncology annual meeting. These
presentations demonstrate the importance of using a 25-gene panel
to evaluate risk for hereditary breast and ovarian cancers.
“Risk assessment for hereditary cancer is expanding with the use
of the myRisk Hereditary Cancer 25-gene panel, approximately
doubling the rate of mutation detection over BRCA1/2 testing alone.
However, in these studies we sought to understand the magnitude of
risk across 25 genes,” said Johnathan Lancaster, M.D.,
Ph.D., chief medical officer, Myriad Genetic
Laboratories. “We discovered that mutations in eight genes
are associated with a two- to six-fold increase in breast cancer
risk and mutations in 11 genes confer a two- to 40-fold increased
risk for ovarian cancer. These important findings clarify the risk
across diverse genes and support the use of myRisk as part of a
clinical risk assessment for patients.”
Results of the studies to be presented are described below and
abstracts are available at: abstracts.asco.org. Follow Myriad
on Twitter via @MyriadGenetics to stay informed about news and
updates from the Company.
myRisk Hereditary Cancer Podium
PresentationsTitle: Magnitude of invasive
breast cancer (BC) risk associated with mutations detected by
multiple-gene germline sequencing in 95,561
women.Presenter: Michael Hall, Stanford University
Cancer InstituteDate: Monday, June 6, 2016, 8:00 –
11:30 a.m.; Discussion 1:15 – 2:30 p.m. Location:
S404, Abstract 1512, Poster Board 335
This study evaluated the magnitude of invasive breast cancer
(BC) risk associated with mutations across a 25-gene panel
test. A total of 95,561 patients underwent clinical testing
with the myRisk Hereditary Cancer test. Seven percent of patients
tested positive for a deleterious mutation. The majority of
mutations occurred in BRCA1/2 genes (44 percent) or other genes
associated with BC risk (40 percent). There was a significant
association with personal BC history and mutations in BRCA1/2,
PTEN, TP53, PALB2, CHEK2, BARD1 and ATM. Specifically, estimates
ranged from two (ATM, CHEK2, BARD1) to six (BRCA1, PTEN) times
increased risk for breast cancer. These findings demonstrate the BC
risk across the diverse panel of 25 genes in the myRisk test.
Title: Ovarian cancer risk associated with
mutations detected by multiple-gene germline sequencing in 95,561
women.Presenter: Allison Kurian, Stanford
University Cancer InstituteDate: Monday, June 6,
2016, 9:45 – 11:15 a.m. Location: E450ab,
Abstract: 5510
This study evaluated the magnitude of ovarian cancer (OC) risk
with mutations across the 25 genes included in the myRisk
Hereditary Cancer panel. Data from 95,561 patients were analyzed to
examine the association between deleterious mutations and personal
history of OC. The results showed that seven percent of patients
tested positive for a deleterious mutation. Among 5,020 women
affected by OC, 14 percent had a deleterious mutation (63 percent
with BRCA1/2, 9.4 percent in Lynch Syndrome genes and 11.2 percent
in other genes associated with OC). In this study, 11 genes
were associated with a significant risk of OC, including the first
report of OC risk associated with the ATM gene. Importantly,
one-third of mutations in patients with OC were in non-BRCA and
non-Lynch genes, demonstrating that panel testing with the myRisk
test identified a broader spectrum of associated cancers.
About Myriad myRisk® Hereditary Cancer
TestingThe Myriad myRisk Hereditary Cancer test uses an
extensive number of sophisticated technologies and proprietary
algorithms in an 850 step laboratory process to evaluate 25
clinically significant genes associated with eight hereditary
cancer sites including: breast, colon, ovarian, endometrial,
pancreatic, prostate and gastric cancers and melanoma. For
more information visit:
https://www.myriad.com/products-services/hereditary-cancers/myrisk-hereditary-cancer/.
About Myriad GeneticsMyriad Genetics Inc., is a
leading personalized medicine company dedicated to being a trusted
advisor transforming patient lives worldwide with pioneering
molecular diagnostics. Myriad discovers and commercializes
molecular diagnostic tests that: determine the risk of developing
disease, accurately diagnose disease, assess the risk of disease
progression and guide treatment decisions across six major medical
specialties where molecular diagnostics can significantly improve
patient care and lower healthcare costs. Myriad is focused on
three strategic imperatives: transitioning and expanding its
hereditary cancer testing markets, diversifying its product
portfolio through the introduction of new products and increasing
the revenue contribution from international markets. For more
information on how Myriad is making a difference, please visit the
Company's website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris
AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer,
myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx,
myChoice HRD, Vectra and Prolaris are trademarks or registered
trademarks of Myriad Genetics, Inc. or its wholly owned
subsidiaries in the United States and foreign countries. MYGN-F,
MYGN-G
Safe Harbor StatementThis press release
contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, including
statements related to the presentation of data from two clinical
studies at the 2016 American Society of Clinical Oncology annual
meeting to be held June 3-7, 2016 in Chicago, Ill; key podium
presentations highlighting the safety and validity of the myRisk
Hereditary multigene panel test in assessing hereditary cancer
risk; the myRisk Hereditary Cancer studies presented at ASCO
advancing the state-of-the-art of hereditary cancer testing; the
new data providing additional evidence for the safety and clinical
utility of the myRisk Hereditary Cancer test to help improve and
save the lives of patients; and the Company's strategic directives
under the caption "About Myriad Genetics." These
"forward-looking statements" are based on management's current
expectations of future events and are subject to a number of risks
and uncertainties that could cause actual results to differ
materially and adversely from those set forth in or implied by
forward-looking statements. These risks and uncertainties include,
but are not limited to: the risk that sales and profit margins of
our molecular diagnostic tests and pharmaceutical and clinical
services may decline; risks related to our ability to transition
from our existing product portfolio to our new tests, including
unexpected costs and delays; risks related to decisions or changes
in governmental or private insurers’ reimbursement levels for our
tests or our ability to obtain reimbursement for our new tests at
comparable levels to our existing tests; risks related to increased
competition and the development of new competing tests and
services; the risk that we may be unable to develop or achieve
commercial success for additional molecular diagnostic tests and
pharmaceutical and clinical services in a timely manner, or at all;
the risk that we may not successfully develop new markets for our
molecular diagnostic tests and pharmaceutical and clinical
services, including our ability to successfully generate revenue
outside the United States; the risk that licenses to the technology
underlying our molecular diagnostic tests and pharmaceutical and
clinical services and any future tests and services are terminated
or cannot be maintained on satisfactory terms; risks related to
delays or other problems with operating our laboratory testing
facilities and our healthcare clinic; risks related to public
concern over genetic testing in general or our tests in particular;
risks related to regulatory requirements or enforcement in the
United States and foreign countries and changes in the structure of
the healthcare system or healthcare payment systems; risks related
to our ability to obtain new corporate collaborations or licenses
and acquire new technologies or businesses on satisfactory terms,
if at all; risks related to our ability to successfully integrate
and derive benefits from any technologies or businesses that we
license or acquire; risks related to our projections about our
business, results of operations and financial condition; risks
related to the potential market opportunity for our products and
services; the risk that we or our licensors may be unable to
protect or that third parties will infringe the proprietary
technologies underlying our tests; the risk of patent-infringement
claims or challenges to the validity of our patents or other
intellectual property; risks related to changes in intellectual
property laws covering our molecular diagnostic tests and
pharmaceutical and clinical services and patents or enforcement in
the United States and foreign countries, such as the Supreme Court
decision in the lawsuit brought against us by the Association for
Molecular Pathology et al; risks of new, changing and competitive
technologies and regulations in the United States and
internationally; and other factors discussed under the heading
"Risk Factors" contained in Item 1A of our most recent Annual
Report on Form 10-K for the fiscal year ended June 30, 2015, which
has been filed with the Securities and Exchange Commission, as well
as any updates to those risk factors filed from time to time in our
Quarterly Reports on Form 10-Q or Current Reports on Form
8-K. All information in this press release is as of the date
of the release, and Myriad undertakes no duty to update this
information unless required by law.
Media Contact: Ron Rogers
(908) 285-0248
rrogers@myriad.com
Investor Contact: Scott Gleason
(801) 584-1143
sgleason@myriad.com
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